Why is a stand alone index needed? Those of you who are involved in real world studies (RWS) know that trying to file your documents using the existing TMF Reference Model (TMF RM) based on ICH E6 can be challenging. Your study isn’t a clinical trial and as a result, at least 40% of the […]
Announcing: Real-World Study Document Index Read More »
TMF Reference Model “Guidance for the Management of e-Mail Communications in Clinical Studies” v1.0 Published 31-Jul-2020 This “Guidance for the Management of e-Mail Communications in Clinical Studies” is intended to provide recommendations to the life sciences industry on the management of e-mail communications generated throughout the conduct of a clinical study. Topics covered include: best
Announcing: Guidance for Managing Trial-related Emails Read More »
Elections to fill the five vacancies on the Steering Committee will open at 5pm BST on Monday 30th March 2020. All active project members (registered on groups.io) will receive an invitation to cast a vote for up to five of the eight candidates, with voting open until Friday 10th April 2020. Details about candidates can
Steering Committee Elections Read More »
The MHRA have just published a great blog post on the topic of MHRA expectations for GCP inspections. We won’t repeat the information here…. just click the link to go to the MHRA Blog!
The do’s and don’ts of (MHRA) inspections Read More »
Please add your voice to the only non-commercial, annual industry-wide Trial Master File Survey! Make sure your perspective is heard and get valuable insights and data for your TMF improvement initiatives. This survey – developed by the TMF Reference Model Project Team – is designed to provide insight into TMF details and practices from sponsors,
Reminder: TMF Industry Survey Now Open Read More »
Please add your voice to the only non-commercial, annual industry-wide Trial Master File Survey! Make sure your perspective is heard and get valuable insights and data for your TMF improvement initiatives. This survey – developed by the TMF Reference Model Project Team – is designed to provide insight into TMF details and practices from sponsors,
TMF Industry Survey Now Open Read More »
Our new online discussion forum is now available…. just click on the Forum link on the main menu. Those who have been involved with the TMF Reference Model project for a while will know that we’ve used Yahoo!Groups for several years. However, it is not always so convenient having groups of users managed in different
New Discussion Forum Launched Read More »
Following the recent Steering Committee elections, we are pleased to announce the new committee, effective 1 May 2019: Elected/Re-elected:Karen Roy – PhlexglobalMarie-Christine Poisson – Pfizer Sholeh Ehdaivand – LMK Clinical Research ConsultingAllison Varjavandi – Astellas Continuing members:Jamie Toth – Daiichi SankyoFran Ross – CGILisa Mulcahy – Mulcahy Consulting LLCScott McCulloch – InClinTodd Tullis – VeevaPaul
Changes to TMF Reference Model Steering Committee Read More »
Following the receipt of clarification from the MHRA on access to the investigator TMF, the Q&A document that was generated following the European TM Summit has been revised. The document has been updated as follows. “Slides were based on the draft of the TMF guidance at that time. The Q&A question 27 answer is compatible and
MHRA Q&A Document Revised Read More »
Final reminder that our next free Exchange Mechanism Standard (EMS) webinar is on Thursday December 13 at 7am PT, 10am ET, 3pm UTC, 4pm CET, kindly hosted by Wingspan Technology (an IQVIA company). Learn about the key success factors facing life sciences professionals in embracing the emerging TMF Exchange Mechanism Standard. Register directly by clicking HERE.
FREE Webinar: Embracing the TMF Exchange Mechanism Standard Read More »
